Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

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Time to healing of target ulcer, defined as the treatment period day during the weekly visit at which the surface area of the wound was noted as zero and completely healed [ Time Frame: Week 12 ]

Original Primary Outcome Measures ICMJE (submitted: October 19, 2009)

Time to healing of target ulcer, defined as the treatment period day during the weekly visit at which the surface area of the wound was noted as zero and completely healed [ Time Frame: Week 12 / Week 24 ]

Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and will be hold in place by a secondary dressing for maintaining the moist wound environment. The study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. The primary efficacy variable is time to healing.

Depth: Involving dermis, with no exposed muscle, tendon or bone. Characterized by a viable wound bed with granulation tissue

The etiology of the ulcer as "venous" is proven by Duplex or Doppler sonography and with ankle/brachial arterial Doppler pressure index > 0.8 (exclusion criterion for peripheral arterial disease) and < 1.3 (exclusion criterion for medial sclerosis), or with a laser Doppler value > 40

Treatment with active wound care agents paused for 14 days before start of study treatment

Exclusion Criteria:

Only ulcers of other than venous etiology, e.g., diabetic ulcers or ulcers resulting from electrical, chemical, or radiation insult, after contact eczema, etc.

History of radiotherapy to the target ulcer site

Signs of infection as defined by rubor, dolor, calor, tumor, functio laesa. Fever (38°C sublingual, rectal, or ear), rigors, or leukocytosis will be considered as signs of infection in the context of the general appearance of the wound